[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zulfa Omer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100601323","phase-2-study-of-epcoritamab-as-a-consolidation-therapy-in-cllsll-100601323",false,"NCT07108998","Study of Epcoritamab as a Consolidation Therapy in CLL\u002FSLL","A Phase 2 Study of Epcoritamab as a Consolidation Therapy for 2nd Generation BTKi +\u002F- Obinutuzumab in CLL\u002FSLL Patients or Variants of This.","Inclusion Criteria\n\n1. Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL\u002FSLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab for a minimum of 12 months as first line therapy.\n\n   a) Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH\u002FCytogenetics translocations(del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL.\n2. Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.\n3. Age ≥18 years.\n4. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).\n5. Patients must have adequate organ and marrow function as defined below:\n\n   Absolute neutrophil count ≥1,000\u002FmcL, unless if neutropenia is due to underlying CLL bone marrow disease.\n\n   Hemoglobin ≥8 g\u002Fdl unless if related to underlying CLL Platelets ≥50,000\u002F µL unless if related to underlying CLL Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (excepting Gilbert's syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the UC PI).\n\n   AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Glomerular filtration rate (GFR) Calculated GFR using CKD-EPI formula ≥ 30 (See Appendix E) or multiplying the estimate of GFR by an individual body surface area calculated using an appropriate formula and dividing by 1.73 m2.\n6. Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 4 months after discontinuing study drug:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.\n   2. Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.\n   3. Intrauterine device.\n   4. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.\n7. Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation.\n8. Non-sterile males must refrain from sperm donation, from initial study drug administration until 4 months after the last dose of study drug.\n9. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n1. Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +\u002F- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.\n2. Absence of CD20 expression on CLL cells at pre-treatment.\n3. Received any prior treatment ever with a CD3×CD20 bispecific antibody.\n4. Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.\n5. Receipt of a live vaccine within 28 days prior to study treatment initiation.\n6. Autoimmune diseases requiring high dose immunosuppressives (e.g., above 20 mg prednisone daily).\n7. Central nervous system (CNS) disease(s) unless in the opinion of the investigator these would not preclude the patient from participation.\n8. Known hypersensitivity to any of the components of the treatment drugs (see Investigators Brochure for a list of components).\n9. Patients with active Richter's transformation.\n\n   a. Note: the following will be eligible and not excluded: patients with accelerated phase or prolymphocytic progression\n10. Patients who have received prior radiation therapy (RT) unless in the opinion of the investigator the prior receipt of RT will not adversely impact the patient's ability to participate.\n11. Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.\n12. Major surgery within 14 days prior to the first dose of study drug.\n13. Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.\n14. Pregnant women, those planning to become pregnant during the study, and\u002For breastfeeding women are ineligible for participation.\n15. Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    1. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). No new IV therapy or intravenous antibiotics may be initiated within 2 weeks prior to first dose of study drug.\n    2. Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive)\n    3. Unexplained fever \\> 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at the discretion of the Investigator).\n16. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.","ALL","18 Years",{"count":19,"type":20},22,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +\u002F- Obinutuzumab in CLL\u002FSLL patients or patients with variants of this.",[26,27,28,29,30,31,32],"CLL\u002FSLL","CLL","SLL","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Small Lymphocytic Lymphoma Variant","Chronic Lymphocytic Leukemia Variants",[34,35],"Epcoritamab","Obinutuzumab","RECRUITING","2026-01-02",{"date":39,"type":40},"2026-01-06","ACTUAL",{"date":42,"type":40},"2025-08-22",{"date":44,"type":20},"2029-07-01",{"name":46,"class":47},"Zulfa Omer","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100594090","phase-2-intermittent-versus-continuous-venetoclax-with-acalabrutinib-for-cllsll-100594090","NCT07014917","Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL\u002FSLL","Randomized Phase II Study of Intermittent Versus Continuous Venetoclax Therapy With Acalabrutinib in Previously Untreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This","ESR-23-22182","Inclusion Criteria:\n\n1. Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL\u002FSLL diagnosis that requires therapy by one IWCLL criteria; and, must be previously untreated CLL\u002FSLL.\n\n   a. Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH\u002FCytogenetics translocations (del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL\n2. Men and Women ≥18 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n4. Subjects must have adequate organ and marrow function as defined below:\n\n   1. ANC ≥1,000\u002FmcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500\u002FmcL unless WBC is \\> to 50 x 109\u002FL. If WBC is \\> to 50 x 109\u002FL there will be no lower threshold of ANC. Use of steroids for disease control is allowed.\n   2. Platelets ≥30,000\u002FmcL unless thrombocytopenia is due to extensive underlying CLL bone marrow disease platelets threshold will be ≥ 10, 000\u002Fmcl. Use of steroids for disease control is allowed.\n   3. Total bilirubin ≤1.5 x ULN unless directly attributable to Gilbert's syndrome\n   4. AST and ALT ≤3 × ULN\n   5. Creatinine clearance (Cockcroft) ≥30 mL\u002Fmin\u002F1.73 m2 • CrCl by Cockcroft and Gault method: CrCl (mL\u002Fmin) = (140 - age \\[years\\]) × weight (kg) × (F)a (72 × serum creatinine mg\u002FdL a where F = 0.85 for females and F = 1 for males ≥ 30 mL\u002Fminute\n5. Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.\n6. Male subjects who are sexually active must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study.\n7. Men must agree to refrain from sperm donation during the study.\n8. Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing tablets without difficulty.\n9. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).\n\nExclusion Criteria:\n\n1. Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.\n2. Patients with active Richter's transformation.\n3. History of or ongoing confirmed central nervous system (CNS) lymphoma.\n4. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.\n5. Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n6. History of prior malignancy that could affect compliance with the protocol or interpretation of results in the opinion of the investigator, except for the following:\n\n   1. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, breast or prostate at any time prior to study that are adequately treated. Patients with cancer not requiring therapy (ex: early prostate cancer under observation, should be discussed with Study PI).\n   2. Continuation of maintenance therapy in patients with adequately treated malignancy\n   3. Other cancers not specified above that have been curatively treated by surgery and\u002For radiation therapy and\u002For chemotherapy from which subject is disease-free for ≥3 years without further treatment\n7. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at Screening.\n\n   a. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.\n8. Patients with a condition that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment. For example, refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection.\n9. Received a live virus vaccination within 28 days of first dose of study drug.\n10. Uncontrolled HIV infection.\n11. History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).\n12. Any active uncontrolled significant infection (e.g., bacterial, viral or fungal), including subjects with positive cytomegalovirus \\[CMV\\] DNA polymerase chain reaction \\[PCR\\]).\n13. Serologic status reflecting active hepatitis B or C infection.\n\n    1. Note: Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded.\n    2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.\n14. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n15. Uncontrolled bleeding diathesis (e.g., hemophilia, von Willebrand disease).\n16. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n\n    a. Note: DOAC or LMWH are not exclusionary.\n17. Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited. Patient who have started those inhibitor or inducers with known dose outside above timeline will follow dose reduction schedule provided in the protocol and package insert of venetoclax and acalabrutinib.\n18. Breastfeeding or pregnant.\n19. Concurrent participation in another therapeutic clinical trial.\n20. Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.\n21. Requires treatment with P-glycoprotein (P-gp) inhibitor during venetoclax initiating and dose escalation phase.\n\n    Note: After initiation of the study drug(s) once a stable dose is reached if P-gp inhibitors are required then these P-gp inhibitors will be allowed per the reduction tables within the protocol or per the study drug(s) package insert\u002FIB.\n22. Patients who are unable to receive Prevnar vaccination.",{"count":58,"type":20},62,[23],"This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)",[29,30,62],"CLL Variant",[64,65,27,28],"Venetoclax","Acalabrutinib",{"date":39,"type":40},{"date":68,"type":40},"2025-12-05",{"date":70,"type":20},"2032-06-05",{"name":46,"class":47},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":48},"100591258","phase-2-lp-168-and-obinutuzumab-for-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-and-variants-of-this-100591258","NCT06978088","LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This","A Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This","Inclusion Criteria:\n\n1. Diagnosis of CLL or SLL meeting criteria established in the 2018 iwCLL criteria and requiring treatment. Patients with variation in flow cytometry findings will be allowed to enroll if cytogenetics and\u002For mutational studies are supportive of CLL\u002FSLL variant.\n\n   a) Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH\u002FCytogenetics translocations(del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL.\n2. Meet the criteria for inclusion into at least one of the following 2 cohorts:\n\n   1. Cohort 1: One or more prior therapies for CLL\u002FSLL including BCL2 inhibitor (BCL2i), and\u002For chemotherapy and\u002For BTK inhibitor (BTKi).\n\n      • Note: Patients can be eligible if their CLL\u002FSLL has been non-responsive to a covalent and noncovalent BTKi. Patients intolerant to BTKi whose disease becomes resistant to a second one are eligible to enroll. Prior treatment with CD20 will not be exclusionary.\n   2. Cohort 2: Treatment with a prior BTKi (covalent and noncovalent) and have a BTK gatekeeper mutation in the T474 coordinate.\n3. Age ≥18 years.\n4. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).\n5. Patients must have adequate organ and marrow function as defined below:\n\n   1. ANC ≥1,000\u002FmcL, unless if neutropenia is due to underlying CLL bone marrow disease.\n   2. Platelets ≥ 50,000\u002F µL unless if thrombocytopenia is due to underlying CLL bone marrow disease then platelets of ≥20,000 is acceptable\n   3. Total bilirubin ≤1.5 x ULN (excepting Gilbert's syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the UC PI).\n   4. AST and ALT ≤2.5 × ULN.\n   5. Estimated glomerular filtration rate (by Modification of Diet in Renal Disease \\[MDRD\\]) or Chronic Kidney Disease Epidemiology \\[CKD-EPI\\]) ≥ 30 mL\u002Fmin\n6. Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 30 days after discontinuing study drug:\n\n   1. Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.\n   2. Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.\n   3. Intrauterine device.\n   4. Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.\n7. Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation.\n8. Non-sterile males must refrain from sperm donation, from initial study drug administration until 30 days after the last dose of study drug.\n9. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with active Richter's transformation.\n2. Patient has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n   1. Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc.\n   2. Any investigational therapy, including targeted small molecule agents.\n   3. For patients who come off BCR antagonist treatment (BTK inhibitors, PI3K inhibitors, etc.), allow washout for 5 half-lives as these patients progress quickly after treatment discontinuation and then remain eligible (steroids may be given during the washout to allow for disease control, see d below for details).\n   4. When a patient's intercurrent health condition would require short term steroid use this should be discussed with the Investigator in consultation with the Medical Monitor. Steroids are allowed for disease control in those R\u002FR patients when use is limited to 2-3 days to allow for control of the underlying disease. Steroids may be given during the washout to allow for disease control.\n3. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.\n4. Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.\n5. Major surgery within 14 days prior to the first dose of study drug.\n6. Patients who have received the following medications or therapies within 5 half-lives or 14 days, whichever is shorter, prior to the first dose of study drug:\n\n   1. Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti- neoplastic intent (except as noted in exclusion criterion #2).\n   2. Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors (see the list in Appendix B)\n   3. Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort (Appendix B)\n   4. There is a 28-day washout period required for patients who have had prior CAR T treatment if there is no evidence of cytokine release syndrome (CRS) or other AEs related to the CAR T treatment per discussion with the UC PI; reduced washout period may be acceptable after discussion with UC PI.\n   5. Drugs that are substrates of MATE1 and MATE2-K should be avoided or substituted for other medications if possible. Use of these (if done) must be discussed with the PI of the study. (Appendix D).\n7. Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or Star fruit within 3 days prior to the first dose of study drug.\n8. Patient requires treatment with systemic acid-reducing agents, H2 blocking agent and proton pump inhibitors, with the following exceptions:\n\n   1. Proton pump inhibitors should be discontinued at least 7 days or at least 5-half-lives (whichever is shorter) prior and held throughout the study.\n   2. If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2 - 3 hours after the next dose of LP-168.\n   3. If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n9. Patient has clinically significant screening electrocardiogram (ECG) abnormalities including:\n\n   1. 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTcF) ≥ 480ms (calculated per Fridericia's formula \\[QTcF = QT\u002FRR (1\u002F3)\\]).\n   2. For patients with presence of right bundle branch block (RBBB) or left bundle branch block (LBBB), cardiology review is needed to correct QTcF calculation using Sponsor recommended formula (Simplified Formula for Bundle Branch Block). See Appendix C.\n   3. Other clinically significant ECG abnormalities per PI discretion.\n10. Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.\n11. Patient has a history of stroke or intracranial hemorrhage within 180 days prior to the first dose of study drug.\n12. Patients who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks). The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n13. Pregnant women, those planning to become pregnant during the study, and\u002For breastfeeding women are ineligible for participation.\n14. Patients with known malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n15. Known hypersensitivity to any of the components of LP-168 (see Investigators Brochure for a list of components).\n16. Patients with active bleeding disorder.\n\n    a) NOTE: Von Willebrand's disease or hemophilia will not be excluded if patient is on treatment and well controlled.\n17. Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    1. Uncontrolled active systemic infection (bacterial, fungal, viral);\n    2. Known poorly controlled (defined as less than 200 CD4 count) human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive)\n    3. Unexplained fever \\> 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at the discretion of the Investigator).\n18. Patient has a history of other active malignancies within the past 1 year prior to study entry, with the exception of:\n\n    1. Breast cancer or prostate cancer on endocrine therapy with stable disease.\n    2. Continuation of maintenance therapy in patients with adequately treated malignancy.\n    3. Cancer with expected survival of 2 years or more or that will not confound evaluation of LP-168 treatment.\n    4. Adequately treated in situ carcinoma of the cervix uteri.\n    5. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.\n    6. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n    7. Patients with active CNS involvement can be enrolled per Investigator discretion; patients with significant clinical symptoms, including any that require treatment with high dose steroid, will be excluded.",{"count":80,"type":20},34,[23],"Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) and Variants of This.",[84,30,26,29],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[86,35,29,30],"LP-168","2025-08-11",{"date":89,"type":40},"2025-08-14",{"date":91,"type":40},"2025-06-01",{"date":93,"type":20},"2034-06-01",{"name":46,"class":47},""]